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[资源] 【medical-news】又一个“文迪雅” 奥美拉唑会重蹈覆辙么？

http://www.nytimes.com/2007/08/10/health/10drug.html?_r=1&ref=health&oref=slogin
F.D.A. Is Reviewing Heartburn Drugs After Studies Find Possible Heart Risk
WASHINGTON, Aug. 9 — Two small studies of the popular heartburn drugs Prilosec and Nexium found that patients who took the medicines over many years had an increased risk of sometimes fatal heart attacks and heart failure.
But officials at the Food and Drug Administration played down the heart worries, saying that other studies suggested no such risks. The F.D.A. will need another three months to complete a thorough analysis of the drugs’ safety, the officials said in an announcement on Thursday.
In the meantime, doctors and patients should continue to prescribe and use the drugs as before, the officials said.AstraZeneca, the maker of Prilosec and Nexium, released a statement saying that it agreed with the F.D.A.’s preliminary assessment. “Therefore, patients should not change their medication in the light of the study data,” the company said. The agency came under criticism in recent months for failing for more than a year to alert the public to studies that suggested that Avandia, a medicine prescribed for Type 2 diabetes, may increase the risks of heart attacks and angina. Agency officials initially dismissed concerns about Avandia’s safety, but a panel of experts voted verwhelmingly on July 30 that the risks were real.“It’s hard to know if this will play out similarly until we have completed our analyses” of Prilosec and Nexium, said Dr. Paul Seligman, the agency’s associate center director for safety policy and communication. Concerns about Prilosec and Nexium began on May 29 when AstraZeneca sent the F.D.A. the results of a 14-year study of the treatment of reflux disease that compared patients taking Prilosec with those who underwent surgery.Within a year of the study’s inception, patients taking Prilosec were more likely to have heart attacks, heart failure and heart-related sudden death than were those who underwent surgery. The effect continued throughout the study, the drug agency said.A second, continuing study of Nexium found similar risks early in the trial, but this effect seemed to go away as the trial continued, the agency said.The Prilosec study suffered from several weaknesses that could have led to a false suggestion of a risk, the agency said. Patients who underwent surgery tended to be younger and healthier than those who took Prilosec. And 14 other Prilosec studies found no heart risks, it said.“Based on everything we know now, F.D.A.’s preliminary conclusion is that the observed difference in risk of heart attacks and other heart-related problems seen in early analyses of the two small long-term studies is not a true effect,” the agency said in a written statement.The parallels with the Avandia situation are striking, demonstrating the difficulty of trying to assess drug safety issues.In the case of Avandia, a combined analysis of more than three dozen short-term studies revealed a heart risk, but the drug agency largely dismissed this result when a continuing long-term trial did not find such a risk. With Prilosec, a long-term trial suggested a heart risk, but the agency dismissed the finding because 14 briefer studies were more reassuring. Prilosec and Nexium, which are nearly identical, are part of a class of medicines known as proton pump inhibitors that resolve heartburn by reducing the stomach’s production of acid. Among the other drugs in this class are Prevacid, Protonix and Aciphex. The F.D.A. has asked for safety data from the makers of all proton pump inhibitors. Dr. Seligman said. The agency’s announcement about Prilosec and Nexium was the earliest public warning that it had ever made during a safety review, Dr. Seligman said. “We were cognizant from the earliest submission about whether and how we should say something,” Dr. Seligman said.
---------------------------------------------------------------------------------------------------------http://www.nytimes.com/2007/08/10/health/10drug.html?_r=1&ref=health&oref=slogin
F.D.A. Is Reviewing Heartburn Drugs After Studies Find Possible Heart Risk
在可能的心脏风险报告之后 FDA 正在调查胃痛药物
WASHINGTON, Aug. 9 — Two small studies of the popular heartburn drugs Prilosec and Nexium found that patients who took the medicines over many years had an increased risk of sometimes fatal heart attacks and heart failure.
华盛顿8月9日消息，有两个关于现在流行的胃痛药物奥美拉唑和耐信的小型研究发现，服用该两种药物的患者多年之后发生致死性心脏病发作和心理衰竭的风险加大。
But officials at the Food and Drug Administration played down the heart worries, saying that other studies suggested no such risks. The F.D.A. will need another three months to complete a thorough analysis of the drugs’ safety, the officials said in an announcement on Thursday.
但是FDA的官员认为事情没有那么严重，其他的实验并没有提示类似的风险。FDA将在接下去的三个月内完成一项彻底的药物安全性分析，同时，医生和患者还是可以继续像以前一样使用着两个药物，有关官员在周二声明。
In the meantime, doctors and patients should continue to prescribe and use the drugs as before, the officials said.
AstraZeneca, the maker of Prilosec and Nexium, released a statement saying that it agreed with the F.D.A.’s preliminary assessment. “Therefore, patients should not change their medication in the light of the study data,” the company said.
这两种药物的制造商阿斯利康公司也发表声明认同FDA的初期评估，认为患者不该因为这些研究数据改变他们的用药。
The agency came under criticism in recent months for failing for more than a year to alert the public to studies that suggested that Avandia, a medicine prescribed for Type 2 diabetes, may increase the risks of heart attacks and angina.
在最近的几个月中，因为在一年多的时间里没有及时醒大众关注一些提示文迪雅可能存在心脏病发作和心绞痛风险的研究，FDA一直处于舆论的批评中。
Agency officials initially dismissed concerns about Avandia’s safety, but a panel of experts voted overwhelmingly on July 30 that the risks were real.
FDA官员起初是否定了关于文迪雅安全性的质疑，但是7月30日的专家小组以压倒性的优势认定文迪雅的危险性是存在的。
“It’s hard to know if this will play out similarly until we have completed our analyses” of Prilosec and Nexium, said Dr. Paul Seligman, the agency’s associate center director for safety policy and communication.
FDA安全政策和交流联合中心主任Paul Seligman说，在我们完成这项分析之前，很难判定此次事件是否与文迪雅事件的相似。
Concerns about Prilosec and Nexium began on May 29 when AstraZeneca sent the F.D.A. the results of a 14-year study of the treatment of reflux disease that compared patients taking Prilosec with those who underwent surgery.
对于奥美拉唑和耐信的关注始于5月29日，当时阿斯利康将一项研究返流疾病长达14年之久的结果送至FDA，在该研究中，他们将服药的患者与手术的患者进行了比较。
Within a year of the study’s inception, patients taking Prilosec were more likely to have heart attacks, heart failure and heart-related sudden death than were those who underwent surgery. The effect continued throughout the study, the drug agency said.
在试验的第一年，服用奥美拉唑的患者出现心脏病发作、心衰和心脏相关性猝死的现象就比手术的患者多，而且这种现象在试验过程中一直没有改变。
A second, continuing study of Nexium found similar risks early in the trial, but this effect seemed to go away as the trial continued, the agency said.
第二项关于耐信的连贯性试验也出现了类似的风险，但是随着试验的进展，这种风险似乎消失了。FDA声明。
The Prilosec study suffered from several weaknesses that could have led to a false suggestion of a risk, the agency said. Patients who underwent surgery tended to be younger and healthier than those who took Prilosec. And 14 other Prilosec studies found no heart risks, it said.
但是FDA也说，关于奥美拉唑的试验设计存在一些缺陷，这些缺陷有可能导致得出关于风险评估的错误结果，因为进行手术的患者比服用奥美拉唑的患者要更年轻和健康。另外的14个试验并没有发现心脏风险。
“Based on everything we know now, F.D.A.’s preliminary conclusion is that the observed difference in risk of heart attacks and other heart-related problems seen in early analyses of the two small long-term studies is not a true effect,” the agency said in a written statement.
“基于我们目前所知的，FDA 初步的评估结果就是，在对这两个小型的长程研究中所观察到的心脏病发作和其他心脏相关性问题的差异并不是真实的效果”，FDA在书面的声明里说。
The parallels with the Avandia situation are striking, demonstrating the difficulty of trying to assess drug safety issues.
类似的文迪雅事件是惊人的，说明评估药品安全是非常困难的。
In the case of Avandia, a combined analysis of more than three dozen short-term studies revealed a heart risk, but the drug agency largely dismissed this result when a continuing long-term trial did not find such a risk. With Prilosec, a long-term trial suggested a heart risk, but the agency dismissed the finding because 14 briefer studies were more reassuring.
在文迪雅事件当中，四十多项短程研究提示存在心脏风险，但是当一个连贯的长程试验没有发现类似的风险时，FDA很大程度上即否决了先前的结果。对于奥美拉唑，一个长程的试验虽然提示有心脏风险，但是由于14个简短研究并没有得出相似的结果，因此，FDA也否定了先前的结果。
The agency’s announcement about Prilosec and Nexium was the earliest public warning that it had ever made during a safety review, Dr. Seligman said. “We were cognizant from the earliest submission about whether and how we should say something,” Dr. Seligman said.
FDA 所作的声明是在整个安全调查期间最早的警告声明，Seligman说，我们是从最早的投稿知道消息的，接下去才知道该怎么做。[/post]

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